G/SPS/N/EU/760  
3 May 2024  
(24-3567) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Food products  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Draft Commission Implementing Regulation (EU) 
amending Implementing Regulation (EU) No 1321/2013 as regards the deletion of entries 
SF-001 to SF -010 from the Union list of au thorised smoke flavouring primary products 
(Text with EEA relevance) . Language(s):  English . Number of pages:  6 
https://members.wto.org/crnattachments/2024/SPS/EEC/24_02948_00_e.pdf  
https://members.wto.org/crnattachments/2024/SPS/EEC/24_02948_01_e.pdf  
6. Description of content:  The text removes smoke flavo uring primary products from the 
Union list of authorized smoke flavouring primary products.  
The European Food Safety Authority (EFSA), on 28 September 2023, adopted its scientific 
opinions on the safety of the smoke flavouring primary products SF -001, SF -002, SF -003, 
SF-004, SF -005, SF -006, SF -008 and SF -009. In its scientific opinions, the Authority 
concluded that a potential safety concern for genotoxicity for all the eight smoke flavouring 
primary products cannot be ruled out. For the smoke flavouring pr imary products SF -007 
and SF -010 no application for the renewal of the authorization was submitted and the 
authorization expired on 1 January 2024.  
The use of smoke flavourings in or on foods should only be authorised if it is sufficiently 
demonstrated tha t it does not present risks to human health. Therefore, based on the 
scientific opinions of the Authority , the renewal of the authorization of smoke flavouring 
primary products SF -001, SF -002, SF -003, SF -004, SF -005, SF -006, SF -008 and SF -009 is 
refused.  
Since none of the ten products listed in the Union list of smoke flavouring primary products 
are authorized anymore, it is appropriate to remove the relevant references from the 
Annex of Commission Implementing Regulation (EU) No 1321/2013 and to adopt suit able 
transitional measures for the foods containing them.  
In order to allow for a smooth transition, the text lays down that foods containing smoke 
flavouring primary products SF -001, SF -002, SF -003, SF -004, SF -005, SF -006, SF -008 or 
SF-009 that comply wit h the provisions laid down for those smoke flavouring primary 
products in the Union list before the date of entry into force of the draft Regulation may 
continue to be placed on the market and remain on the market until their date of minimum 
durability or use by date if they are placed on the market until (i) 1 July 2029 for food G/SPS/N/EU/760  
 
- 2 - 
 
  categories 1.7 (cheese and cheese products), 8 (meat), 9.2 (processed fish and fishery 
products including crustaceans and molluscs), 9.3 (fish roe) and their corresponding sub -
categories and (ii) 1 July 2026 for all other food categories.  
This notification includes, for information, eight Commission Implementing Decisions, 
addressed to the respective authorization holders, refusing the renewal of the 
authorizations for the smoke fla vouring primary products for which the renewal of the 
authorization was requested.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other  damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:   
− Commission Implementing Decision refusing the renewal of the authorization of 
Scansmoke PB 1110 (SF -001) as a smoke flavouring primary product  
− Commission Implementing Decision refusing the renewal of the authorization of Zesti 
Smoke Code 10 (SF -002) as a smoke flavouring primary product  
− Commission Implementing Decision refusing the renewal of the authorization of Smoke 
Concentrate 809045 (SF -003) as a smoke flavouring primary product  
− Commission Implementing Decision refusing the renewal of the authorization of 
Scansmoke SEF 7525 (SF -004) a s a smoke flavouring primary product  
− Commission Implementing Decision refusing the renewal of the authorization of 
SmokEz C -10 (SF -005) as a smoke flavouring primary product  
− Commission Implementing Decision refusing the renewal of the authorization of 
Smok Ez Enviro -23 (SF -006) as a smoke flavouring primary product  
− Commission Implementing Decision refusing the renewal of the authorization of 
ProFagus -Smoke R709 (SF -008) as a smoke flavouring primary product  
− Commission Implementing Decision refusing the renew al of the authorization of 
Fumokomp (SF -009) as a smoke flavouring primary product  
(available in English)  
10. Proposed date of adoption (dd/mm/yy) : Foreseen in June 2024.  
Proposed date of publication (dd/mm/yy) : Foreseen in June 2024.  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : 20 days after publication in the Official Journal of the European Union (with 
transitional provisions until 1 July 2026 and 1 July 2029 respectively).  
[ ] Trade facilitating measure   
12. Final date for comments: [  ] Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : Thirty days from the date of circulation of this 
notification.  G/SPS/N/EU/760  
 
- 3 - 
 
  Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
available) of other body:   
European Commission  
DG Health and Food Safety, Unit A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu  
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
European Commission  
DG Health and Food Safety, Unit A4 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
E-mail: sps@ec.europa.eu